This is a senior leadership role responsible for overseeing all Medical and Regulatory Affairs in Southeast Asia. You'll be the strategic leader ensuring our products are supported scientifically and compliantly from start to finish. This means driving strong scientific engagement, ensuring we follow all rules and regulations, and working closely with teams across the company to achieve business goals and ultimately benefit patients. You'll be the key link between our global strategies and what happens on the ground in each country.
What You'll Do:
Strategic Vision: Set the overall medical and regulatory strategy for the entire SEA cluster, making sure it aligns with our business objectives and contributes to long-term product planning.
Medical & Regulatory Oversight: Lead all medical activities, ensuring scientific quality, and manage all regulatory affairs, from getting products registered to keeping up with changing rules in each SEA country. You'll ensure full compliance with all local and international standards.
Teamwork & Influence: Collaborate closely with other departments (like commercial and business development) to ensure medical and regulatory priorities support the wider business. You'll use your influence to align various teams.
Governance & Compliance: Put in place strong quality systems and ensure all activities meet regulatory standards, staying ahead of new policies.
People Leadership: Coach and mentor country medical and regulatory heads, building high-performing teams, fostering a culture of accountability, and planning for future talent needs.
External Relations: Represent the company externally in industry groups, with regulators, and in scientific discussions, building strong relationships with key opinion leaders and partners.
What You'll Bring:
Integrity & Purpose: Lead with strong ethics and a clear sense of direction.
Strategic & Business Acumen: You can connect medical and regulatory work directly to business goals.
Scientific & Regulatory Expertise: A strong background in science, a proven track record of compliance, and an innovative mindset in regulatory affairs.
Market Insight: Deep understanding of healthcare markets and external environments in the region.
Collaborative Influencer: Skilled at working across complex organizational structures and influencing diverse teams.
Exceptional Communicator: You can explain complex ideas clearly and build strong relationships.
Adaptability: Able to lead through change and work effectively across different cultures.
Talent Developer: Committed to growing and developing your team members.
Your Background:
Education: An advanced degree in life sciences (like MD, PhD, or similar) is highly preferred.
Experience: At least 10 years in medical affairs and regulatory affairs within the pharmaceutical or biotech industry. Experience working across multiple countries or regions in a matrix organization is a significant advantage.
